VORICONAZOLE GLENMARK 50 MG FILM-COATED TABLETS

PDF Transcript

Package leaflet: Information for the user
Voriconazole Glenmark 50 mg & 200 mg Film-coated Tablets
voriconazole
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Voriconazole Glenmark is and what it is
used for
2. What you need to know before you take
Voriconazole Glenmark
3. How to take Voriconazole Glenmark
4. Possible side effects
5. How to store Voriconazole Glenmark
6. Contents of the pack and other information
1. What Voriconazole Glenmark is and what it is
used for
Voriconazole Glenmark contains the active substance
voriconazole.Voriconazole Glenmark is an antifungal
medicine. It works by killing or stopping the growth of
the fungi that cause infections.
It is used for the treatment of patients (adults and
children over the age of 2) with:
• invasive aspergillosis (a type of fungal infection due
to Aspergillus sp),
• candidaemia (another type of fungal infection due
to Candida sp) in non-neutropenic patients (patients
without abnormally low white blood cells count),
• serious invasive Candida sp. infections when the
fungus is resistant to fluconazole (another antifungal
medicine),
• serious fungal infections caused by Scedosporium
sp. or Fusarium sp. (two different species of fungi).
Voriconazole Glenmark is intended for patients with
worsening, possibly life threatening fungal infections.
This product should only be taken under the supervision
of a doctor.
2. What you need to know before you take
Voriconazole Glenmark
Do not take Voriconazole Glenmark
• If you are allergic to voriconazole or any of the other
ingredients of this medicine (listed in section 6)
• If you are taking certain other medicines – see “Other
medicines and Voriconazole Glenmark”
Voriconazole Glenmark must not be taken if you are
already taking any of the following medicines:
• Terfenadine (used for allergy)
• Astemizole (used for allergy)
• Carbamazepine (used to treat seizures)
• Cisapride (used for stomach problems)
• Pimozide (used for treating mental illness)
• Quinidine (used for irregular heart beat)
• Rifampicin (used for treating tuberculosis)
• Phenobarbital (used for severe insomnia and
seizures)
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine;
used for migraine)
• Sirolimus (used in transplant patients)
• Ritonavir (for treating HIV) in doses of 400 mg and
more twice daily
• St John’s Wort (herbal supplement)
• Efavirenz (used for treating HIV) in doses of 400 mg
and above once daily
Warnings and precautions
Talk to your doctor or pharmacist before taking
Voriconazole Glenmark:
• If you have ever had an allergic reaction to any
similar medicines (e.g. ketoconazole, fluconazole).
• If you are suffering from, or have ever suffered from
liver disease. Your doctor may prescribe a lower
dose and monitor your liver function by doing blood
tests.
• If you have any of the following heart problems:
cardiomyopathy, irregular heartbeat, slow heart rate
or an abnormality of electrocardiogram (ECG) called
‘long QT syndrome’.
You should avoid sunlight and sun exposure while
being treated. You should cover exposed areas
of skin and use sunscreen, as this medicine can
increase sensitivity of skin to the sun’s UV rays. These
precautions are also applicable to children.
While being treated with Voriconazole Glenmark:
• tell your doctor immediately if you develop
o sunburn
o severe skin rash or blisters
o bone pain.
If you develop skin disorders as described above, your
doctor may refer you to a dermatologist, who after
consultation may decide that it is important for you
to be seen on a regular basis. There is a small chance
that skin cancer could develop with long-term use of
Voriconazole Glenmark.
While being treated with Voriconazole Glenmark your
doctor will monitor the function of your liver and kidney
by doing blood tests.
Children and adolescents
Voriconazole Glenmark should not be given to children
younger than 2 years of age.
Other medicines and Voriconazole Glenmark
Tell your doctor or pharmacist if you are taking, have

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recently taken or might take any other medicines.
Some medicines, when taken at the same time
as Voriconazole Glenmark, may affect the way
Voriconazole Glenmark works or Voriconazole
Glenmark may affect the way they work.
Tell your doctor if you are taking any of the following
medicine, as treatment with Voriconazole Glenmark at
the same time should be avoided if possible:
• Ritonavir (used for treating HIV) in doses of 100 mg
twice daily
Tell your doctor if you are taking either of the following
medicines, as treatment with Voriconazole Glenmark at
the same time should be avoided if possible, and a dose
adjustment of voriconazole may be required:
• Rifabutin (used for treating tuberculosis). If you
are already being treated with rifabutin your blood
counts and side effects to rifabutin will need to be
monitored.
• Phenytoin (used to treat epilepsy). If you are
already being treated with phenytoin your blood
concentration of phenytoin will need to be monitored
during your treatment with Voriconazole Glenmark
and your dose may be adjusted.
Tell your doctor if you are taking any of the following
medicines, as a dose adjustment or monitoring may be
required to check that the medicines and/ or Voriconazole
Glenmark are still having the desired effect:
• Warfarin
and
other
anticoagulants
(e.g.
phenprocoumon, acenocoumarol; used to slow down
clotting of the blood)
• Ciclosporin (used in transplant patients)
• Tacrolimus (used in transplant patients)
• Sulphonylureas (e.g. tolbutamide, glipizide and
glyburide) (used for diabetes)
• Statins (e.g. atorvastatin, simvastatin) (used for
lowering cholesterol)
• Benzodiazepines (e.g. midazolam, triazolam) (used
for severe insomnia and stress)
• Omeprazole (for treating ulcers)
• Oral contraceptives (if you take Voriconazole
Glenmark whilst using oral contraceptives, you
may get side effects such as nausea and menstrual
disorders)
• Vinca alkaloids (e.g. vincristine and vinblastine)
(used to treat cancer)
• Indinavir and other HIV protease inhibitors (used for
treating HIV)
• Non-nucleoside reverse transcriptase inhibitors (e.g.
efavirenz, delavirdine, nevirapine) (used for treating
HIV) (some doses of efavirenz can NOT be taken at
the same time as Voriconazole Glenmark)
• Methadone (to treat heroin addiction)
• Alfentanil and fentanyl and other short acting opiates
such as sufentanil (painkillers used for surgical
procedures)
• Oxycodone and other long acting opiates such as
hydrocodone (used for moderate to severe pain)
• Non-steroidal anti-inflammatory drugs (e.g.
ibuprofen, diclofenac) (for treating pain and
inflammation)
• Fluconazole (for fungal infections)
• Everolimus (for treating advanced kidney cancer and
in transplant patients)
Pregnancy, breast-feeding and fertility
Voriconazole Glenmark must not be taken during
pregnancy, unless your doctor tells you to. Women of
childbearing age should take effective contraception.
Contact your doctor immediately if you become
pregnant while taking these tablets.
Voriconazole Glenmark must not be taken during breastfeeding. Ask your doctor or pharmacist for advice before
taking any medicine whilst breast-feeding.
Driving and using machines:
Voriconazole may cause blurred vision or uncomfortable
sensitivity to light. If you are affected, do not drive or
operate any tools or machines and contact your doctor.
Voriconazole Glenmark contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Voriconazole Glenmark
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Take your tablet at least one hour before, or one hour
after a meal. Swallow the tablet whole with some
water.
Your doctor will determine your dose depending on
your weight and the type of infection you have.
The recommended dose for adults (including elderly
patients) is as follows:
Dose
Patients 40 kg Patients less
and above
than 40 kg
Dose for the
400 mg every
200 mg every
first 24 hours
12 hours for the 12 hours for the
(Loading Dose) first 24 hours
first 24 hours
Dose after the 200 mg twice
100 mg twice
first 24 hours
a day
a day
(Maintenance
Dose)
Depending on your response to treatment, your doctor
may increase the daily dose to 300 mg twice a day.
The doctor may decide to decrease the dose if you have
mild to moderate liver disease.

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Use in children and adolescents
The recommended dose for children and teenagers is as
follows:
Children aged Adolescents
aged 12 to 14
2 to less than
years weighing
12 years and
50 kg or
adolescents
more; and all
aged 12 to 14
years weighing adolescents
less than 50 kg older than 14
Dose for the
Your treatment 400 mg every
first 24 hours
will be started
12 hours for the
(Loading Dose) with an infusion first 24 hours
(drip)
Dose after the 9 mg per kg
200 mg twice
first 24 hours
a day
of bodyweight
(Maintenance
twice a day (a
Dose)
maximum dose
of 350 mg twice
daily)
Depending on your response to treatment, your doctor
may increase or decrease the daily dose.
Tablets must only be given if the child is able to swallow
tablets.
If you take more Voriconazole Glenmark than you
should
If you take more tablets than prescribed (or if someone
else takes your tablets) you must seek medical advice
or go to the nearest hospital casualty department
immediately. Take your box of tablets with you. You
may experience abnormal intolerance to light as a
result of taking more Voriconazole Glenmark than you
should.
If you forget to take Voriconazole Glenmark
It is important to take Voriconazole Glenmark tablets
regularly at the same time of day. If you forget to take
one dose, take your next dose when it is due. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Voriconazole Glenmark
It has been shown that taking all doses at the appropriate
times may greatly increase the effectiveness of your
medicine. Therefore unless your doctor instructs
you to stop treatment, it is important to keep taking
Voriconazole Glenmark correctly, as described above
Continue taking Voriconazole Glenmark until your
doctor tells you to stop, Do not stop treatment because
your infection may not be cured. Patients with a
weakened immune system or those with difficult
infections may require long term treatment to prevent
the infection from returning.
When Voriconazole Glenmark treatment is stopped by
your doctor, you should not experience any effects.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any side effects occur, most are likely to be minor
and temporary. However, some may be serious and need
medical attention.
Serious side effects – Stop taking Voriconazole
Glenmark and see a doctor immediately if you
have:
• Jaundice (yellowing of the skin and whites of the
eyes)
• Pancreatitis (abdominal pain)
• Rash
Other side effects:
Very common side effects (may affect more than 1 in
10 people)
• Visual disturbances (change in vision)
• Fever
• Rash
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of the extremities
• Stomach pains
Common side effects (may affect up to 1 in 10 people)
• Flu-like symptoms, inflammation of the sinuses,
chills, weakness
• Anaemia
• Low numbers of cells called platelets that help the
blood to clot, low numbers of some types of white
blood cells or of all types of blood cells, red or purple
discoloration of the skin which may be caused by
low platelet count, other blood cell changes
• Anxiety, depression, tingling, confusion, dizziness,
agitation, trembling, hallucinations and other nervous
symptoms
• Low blood pressure, inflammation of a vein (which
may be associated with the formation of a blood
clot)
• Breathing difficulty, chest pain, fluid accumulation
in the lungs
• Low blood sugar, low blood potassium
• Jaundice, redness of the skin
• Swelling of the lips or face
• Allergic reactions (sometimes severe), including
widespread blistering rash and skin peeling
• Sunburn or severe skin reaction following exposure
to light or sun
• Itchiness
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in blood
tests of kidney function
• Changes in blood tests of liver function
• Inflammation of the gastrointestinal tract
Uncommon side effects (may affect up to 1 in 100
people)
• Enlarged lymph glands (sometimes painful)

17.07.14

• Increase in a type of white blood cell which may be
associated with allergic reaction, disorder of blood
clotting system
• Heart rhythm problems including very fast heartbeat,
very slow heartbeat, fainting
• Depressed function of the adrenal gland
• Problem with coordination
• Swelling of the brain
• Double vision pain and inflammation of the eyes and
eyelids, involuntary movement of the eye
• Decreased sensitivity to touch
• Abnormal sense of taste
• Constipation, inflammation of upper small intestine,
dyspepsia, pancreatitis, peritonitis
• Gingivitis
• Swelling and inflammation of the tongue
• Enlarged liver, hepatitis, liver failure, gallbladder
disease, gallstones
• Joint pain, increase in muscle tone
• Inflammation of the kidney, proteins in the urine
• Abnormal electrocardiogram (ECG)
• Blood chemistry changes
• Skin rashes, which may lead to severe blistering and
peeling of the skin
• Swelling or inflammation of the skin, hives, skin
redness and irritation
• Low sodium in the blood
Rare side effects (may affect up to 1 in 1,000 people)
• Inability to sleep
• Hearing difficulties, ringing in the ears
• Muscle weakness caused by an abnormal immune
system response
• Abnormal brain function, Parkinson-like symptoms,
convulsion, nerve injury resulting in numbness, pain,
tingling or burning in the hands or feet
• Severe, persistent or bloody diarrhoea associated
with abdominal pain or fever
• Overactive or underactive thyroid gland
• Damage to the optic nerve resulting in vision
impairment, eye bleeding, abnormal eye movement,
clouding of the cornea
• Damage to the kidneys
• Lymph infection, loss of consciousness due to liver
failure
As Voriconazole Glenmark has been known to affect
the liver and the kidney, your doctor should monitor the
function of your liver and kidney by doing blood tests.
Please advise your doctor if you have any stomach pains
or if your stools have a different consistency.
If any of these side effects persist or are troublesome,
please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via Yellow Card SchemeWebsite: www.mhra.
gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this
medicine.
5. How to store Voriconazole Glenmark
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the carton and blister after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage
conditions.
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Voriconazole Glenmark contains
• The active substance is voriconazole. Each tablet
contains either 50 mg or 200 mg voriconazole
• The other ingredients are Lactose monohydrate,
Maize Starch, Croscarmellose sodium, Povidone,
Talc and Magnesium stearate which make up the
tablet core and Hypromellose, Titanium dioxide
(E171), Lactose monohydrate and Triacetin which
make up the film-coat.
What Voriconazole Glenmark looks like and contents
of the pack
50 mg film-coated tablets: white to off white circular
biconvex film-coated tablets, debossed with ‘73’ on one
side and G on other side.
200 mg film-coated tablets: white to off white oval filmcoated tablets, debossed with ‘573’ on one side and G
on other side.
The tablets are available in PVC/PVdC hard tempered
Aluminium blister pack in cartons of 1, 20, 28, 30, 50,
56 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue,
Harrow, Middlesex
United Kingdom
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143,566 17 Vysoké Mýto,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park
Croxley Green
Hertfordshire, WD18 8YA
United Kingdom
This leaflet was last revised in 07/2014.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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